Contact information
Type
Scientific
Primary contact
Dr Richard Schlenk
ORCID ID
Contact details
University Ulm Medical School
Department of Internal Medicine III
Ulm
89081
Germany
-
richard.schlenk@uniklinik-ulm.de
Type
Scientific
Additional contact
Dr Michael Brach
ORCID ID
Contact details
Institute of Sport Science
University of Muenster
-
-
Germany
-
michael.brach@uni-muenster.de
Type
Scientific
Additional contact
Dr Eva-Maria Panfil
ORCID ID
Contact details
Institute of Applied Nursing Sciences
St. Gallen University of Applied Sciences
-
-
Switzerland
-
evamaria.panfil@fhsg.ch
Type
Scientific
Additional contact
Dr Jörn Rittweger
ORCID ID
Contact details
Institute for Biomedical Research into Human Movement and Health
Manchester Metropolitan University
-
-
United Kingdom
-
j.rittweger@mmu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI-PNP-_01_10 (sponsor), DJCLS R 09/22 (funder)
Study information
Scientific title
Effects of whole-body vibration exercise in addition to care-related exercise according to the Viv-Arte® nursing conception on motor control, motor function and muscular strength: a randomised controlled trial in chemotherapy-related polyneuropathy
Acronym
Study hypothesis
Based on a further development of kinesthetic nursing, Viv-Arte® Training conception (VAT) includes
1. Manual therapy
2. Gymnastic exercise
3. Functional training
Whole-body vibration has proved to help persons who are bedridden or otherwise unable to exercise, maintaining muscular strength needed for activities of daily living. It is hypothised, that patients suffering from chemotherapy-related polyneuropathy could also benefit from whole-body vibration exercise, when added to VAT. Therefore, the trial at hand compares randomised groups treated with VAT versus VAT + whole-body vibration.
Ethics approval
University of Ulm (Germany) Ethics Board, 25/05/2010, ref: 27/10 UBB/bal
Study design
Open-label single-centre randomised active controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Polyneuropathies, secondary to haematologic neoplasms and chemotherapy
Intervention
Control group and experimental group:
15 sessions (two per week) of 60 minutes each, containing VAT manual therapy and functional training. The latter will be skipped for patients who are not reliant upon personal assistance for mobility tasks (according to MOTPA, see secondary outcome measurements). Gymnastic exercise is instructed individually during the session, but should be conducted between sessions. Patients receive a diary and a pedometer for documentation of exercise including walking.
Experimental group only:
In each session, whole-body vibration exercise is integrated after manual therapy. Using a Galileo® training platform, a side-alternating motion similar to a seesaw movement is applied. Amplitude and frequency are variable and will be individually adjusted.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Chair Rising Test (5 times standing up from a chair) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session
Secondary outcome measures
1. Bipedal jump test and balance test using a force plate (Leonardo® Mechanography) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session
2. Functional mobility measured using motor tests including the Timed up and go test (TUG) and the Mobility test for patients in acute care (MOTPA) at baseline and 15th (last) exercise session
3. Quality of life, measured using the EORTC Quality of Life Core Questionnaire (QLQ-C30), Version 3.0, at baseline, 15th (last) exercise session, and 4 weeks after last exercise session
4. Neurotoxicity, measured using the FACT/GOG Ntx (Funktional Assessment of Cancer Therapy/Gynecologie Onkcology Group - Neurotoxity) at baseline, 8th exercise session, 15th (last) exercise session, and 4 weeks after last exercise session
5. Paresthesia, measured using the Visual Analogue Scale (VAS) at baseline, 15th (last) exercise session, and 4 weeks after last exercise session
6. Sensory function, measured at baseline and 15th (last) exercise session, using a standardized quantitative sensory testing (QST) battery:
6.1. Thermal detection threshold, using a computer controlled thermode
6.2. Tactile detection threshold, using von-Frey hairs
6.3. Mechanical pain threshold/sensitivity for pinprick and for light touch, including wind-up (series) sensitivity
6.4. Vibration detection threshold, using a tuning fork
6.5. Pressure pain threshold, using a pressure algometer
7. In order to estimate velocity of nerve conduction as well as sensory and motor evoked potentials (SNAP, MEP), additional electrophysiological measurements will be taken on the discretion of the neurologist
Overall trial start date
01/07/2010
Overall trial end date
30/06/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 and 70 years
2. Polyneuropathy diagnosed (MeSH D011115)
3. Ongoing or finished chemotherapy due to hematologic neoplasms (MeSH D019337)
4. Contiguity between polyneuropathy and chemotherapy supposable
5. Chair Rising Test with pathological score (> 10 s)
6. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
122
Participant exclusion criteria
1. Blood coagulation disorder
2. Infection beyond control
3. Thrombosis within 6 months before the trial
4. Severe neurological or psychiatric disorder, which might impair the validity of informed consent or the compliance with trial interventions
5. Epilepsy
6. Pregnacy
Recruitment start date
01/07/2010
Recruitment end date
30/06/2014
Locations
Countries of recruitment
Germany
Trial participating centre
University Ulm Medical School
Ulm
89081
Germany
Sponsor information
Organisation
University Ulm Medical School (Germany)
Sponsor details
Nursing Management
Albert-Einstein-Allee 29
Ulm
89081
Germany
+49 (0)731 50043055
elisabeth.kirchner@uniklinikum-ulm.de
Sponsor type
University/education
Website
http://www.uniklinik-ulm.de/struktur/zentrale-einrichtungen/pflegedienst
Funders
Funder type
Industry
Funder name
German Jose Carrera Leukaemia Foundation (Deutsche José Carrera Leukämie Stiftung e.V.) (Germany) - (DJCLS R 09/22)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NOVOTEC Medical GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Viv-Arte® Bewegungsschule (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28194306